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Class II: temporary or reversible health riskTerminated

Hospira 5% DEXTROSE Injection Recall

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02)

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Mar 25, 2015
Recall ID
D-0417-2015
Check your lot numberHow we source this data

Summary

Hospira recalled 5% DEXTROSE Injection starting Mar 5, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0417-2015 on Mar 25, 2015. Reason: Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Product description

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Lot numbers, UPCs & expiration codes

Lot: 37-042-JT, Exp 1JAN2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0417-2015
Classification
Class II
Status
Terminated
Recall initiated
Mar 5, 2015
FDA report date
Mar 25, 2015
Quantity
94,440 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0417-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
70642
Address
275 N Field Dr
Code information
Lot: 37-042-JT, Exp 1JAN2016
Postal code
60045-2579
Report date
Mar 25, 2015
Product type
Drugs
Recall number
D-0417-2015
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
94,440 bags
Termination date
Dec 9, 2016
Reason for recall
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Voluntary / mandated
Voluntary: Firm initiated
Product description
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
Distribution pattern
Nationwide
Recall initiation date
Mar 5, 2015
Initial firm notification
Letter
Center classification date
Mar 17, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0417-2015, published Mar 25, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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